Colorectal CancerPhase 3NCT00002793
Chemotherapy Via an Implantable Pump Compared With a Subcutaneous Port for Unresectable Liver Metastases in Patients With Resected Colorectal Cancer
A Phase 3 study testing fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving the drugs in different ways may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- fluorouracil and leucovorin calcium
- How many people
- 336 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1991to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Primary colorectal cancer with unresectable liver metastases Less than 75% involvement of the liver Radical resection of primary colon or rectal tumor required No local recurrence or extrahepatic metastases No portal vein thrombosis, ascites, or cirrhosis
PATIENT CHARACTERISTICS: Age: 18 to 76 Performance status: Karnofsky 70%-100% Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 4 mg/dL Alkaline phosphatase no greater than 1,200 U/L Coagulation tests normal Renal: Creatinine no greater than 2.5 mg/dL Other: No prior malignancy
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior intra-arterial chemotherapy for liver metastases No prior hepatic chemoembolization At least 3 months since fluorouracil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.
Read the detailed description
OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- fluorouracil, leucovorin calcium
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2004 (estimated)
- Study startJan 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Lorenz, MD, Study chair, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002793
- Sponsor's protocol ID
- CDR0000064871
- Other IDs
- GER-ALM-03/95, EU-96007
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY
- ClinicalTrials.gov ID
- NCT00002793
- Acronym / sponsor ID
- CDR0000064871
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 1991
- First posted
- 2 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.
Detailed description
OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Lorenz, MD study chair
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.